EchocardiographyRVANGNCT05055089
Short- and Medium-term Results of New Generation Aortic
An observational study of Echocardiography and Aortic Valve, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography, Aortic Valve, Cardiac Surgery
- How many people
- 172 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2021to 6 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients from the Cardiac Surgery Department of the University Hospital of Amiens of Picardy, France, short- and medium-term survival of patients undergoing surgical aortic valve replacement with new-generation bioprostheses compared with patients who received a traditional bioprosthesis.
Who may be able to join
- Retrospectively included all patients examined since 2010.
- Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.
Who cannot join
- Refusal to participate in the patient.
- Patients who have previously had aortic valve surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Keywords
- Echocardiography, Aortic valve, New-generation bioprosthesis, Conventional bioprosthesis, Rapid-deployment bioprosthesis, Sutureless valves, Function prostheses, Cardiac Surgery, Mortality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| new-generation bioprostheses | Patients undergoing surgical aortic valve replacement with new-generation bioprostheses | |
| traditional bioprosthesis | patients who received a traditional bioprosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of mortality rate between both groups
both groups are :
- Patients undergoing surgical aortic valve replacement with new-generation bioprostheses
- Patients who received a traditional bioprosthesis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start6 Sep 2021
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055089
- Sponsor's protocol ID
- PI2021_843_0186
- Acronym
- RVANG
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Medium-term Outcomes of New Generation Biological Aortic Valves in Aortic Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT05055089
- Acronym / sponsor ID
- RVANG / PI2021_843_0186
- Conditions
- Echocardiography, Aortic Valve, Cardiac Surgery, Mortality
- Keywords
- Echocardiography, Aortic valve, New-generation bioprosthesis, Conventional bioprosthesis, Rapid-deployment bioprosthesis, Sutureless valves, Function prostheses, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new-generation bioprostheses | – | –Patients undergoing surgical aortic valve replacement with new-generation bioprostheses |
| traditional bioprosthesis | – | –patients who received a traditional bioprosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from the Cardiac Surgery Department of the University Hospital of Amiens of Picardy, France, short- and medium-term survival of patients undergoing surgical aortic valve replacement with new-generation bioprostheses compared with patients who received a traditional bioprosthesis.
Key inclusion criteria (2 listed)
- Retrospectively included all patients examined since 2010.
- Patients who have aortic valve surgery from the Cardiac Surgery Department of the University Hospital of Amiens.
Key exclusion criteria (2 listed)
- Refusal to participate in the patient.
- Patients who have previously had aortic valve surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Variation of mortality rate between both groups
Time frame: 3 months
both groups are : * Patients undergoing surgical aortic valve replacement with new-generation bioprostheses * Patients who received a traditional bioprosthesis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Echocardiography and Aortic Valve, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of mortality rate between both groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.